Teva Pharmaceuticals is facing a product liability lawsuit following allegations that the company failed to warn patients and doctors about the potentially dangerous effects of their birth control pills. Southern Florida resident, Michelle Smith, filed a complaint to the U.S. District Court concerning masses she developed on her liver, which she claims were caused by Teva’s birth control pills, Seasonique and Seasonale.
In 2003 Smith starting taking Seasonale, and 6 years later switched to Seasonique. In 2013, after 10 continuous years of Teva birth control use, masses were discovered on her liver. Smith argues Teva knew or should have known about the risks involved for prolonged birth control use. The threat of developing hepatic adenomas, hormone-induced liver tumors, is 5 times higher for women taking Seasonale or Seasonique for 5-7 years, and 25 times more likely after more than 9 years of use.
In her lawsuit, Smith indicates that Teva should have known about the association between oral contraceptives and the development of hormone-induced liver tumors. Instead of making the risk clear to patients and the medical community, the lawsuit complains that Teva downplayed these dangers on their warning labels. The 2003 warning label on Seasonale and the 2006 label on Seasonique mention the risk of hepatic adenomas as “rare in the United States.”
Later, in 2010, Teva updated their warning labels, but the risks were still not clearly stated, according to Smith’s lawsuit. The label read:
“Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) [oral contraceptive] users. However, the attributable risk of liver cancers in [oral contraceptive] users is less than one case per million users.”
Smith’s lawsuit cites both labels as deficient by calling the occurrence of liver tumors rare. The second label also removed any mention of hepatic-adenoma, and instead only mentioned the risk of hepatocellular carcinoma. The Seasonique and Seasonale lawsuit not only argues that the warning labels were inadequate but claims Teva was negligent and is responsible for created a defective design.
Michelle Smith is now seeking compensation and punitive damages. To view the full complaint as it was sent to the United States District Court of Florida, click here.
Countless cases of faulty medications pop up each year, and at Schlesinger Law Offices, P.A., we continue to dedicate our efforts to obtaining reparation for victims. Our personal injury attorneys are currently handling cases involving Zofran birth defects, Xarelto, vaginal mesh, dietary supplements, De Puy ASR XL Acetabular, incidents involving DaVinci Robotic systems, and Accutane.
If you or someone you love suffered severe side effects after taking Seasonique, Seasonale, or any of the previously mentioned medicines and medical devices, we want to help.
Contact Schlesinger Law Offices, P.A. for a free consultation!